Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Biogen MA Inc. | Morrisville, NC, United States | Makes the active ingredient and tests it | No problems foundJun 13, 2018 · 9 inspections |
| Patheon Italia S.p.A | Ferentino, Italy | Makes it and tests it | Problems found, fixed voluntarilyFeb 25, 2022 · 7 inspections, 1 with FDA action |
| Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen) | Ravensburg, Germany | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyJul 21, 2023 · 8 inspections |
| PPD Development Ireland Ltd. | Athlone, Ireland | Tests it | Problems found, fixed voluntarilyMar 9, 2023 · 4 inspections |
| Packaging Coordinators, LLC | Philadelphia, PA, United States | Packages it and labels it | Problems found, fixed voluntarilyJan 31, 2025 · 6 inspections |
| Sharp Packaging Services, LLC | Allentown, PA, United States | Packages it and labels it | No problems foundNov 21, 2025 · 7 inspections |
| Vetter Pharma Fertigung GmbH & Co. KG (Langenargen Eisenbahnstrasse) | Langenargen, Germany | Tests it | Problems found, fixed voluntarilyMar 20, 2024 · 8 inspections |
| Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Helmut-Vetter-Strasse) | Ravensburg, Germany | Tests it | Problems found, fixed voluntarilyJul 27, 2022 · 6 inspections |
| Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse) | Ravensburg, Germany | Tests it | Problems found, fixed voluntarilyJul 13, 2022 · 10 inspections |
Product details
- Generic drug
- Efmoroctocog Alfa: every company that makes it
- Form
- kit, intravenous
- Strength
- 1000 [iU] per 3 mL
- Approval
- BLA BLA125487
- On the market since
- Sep 6, 2017
- Package NDCs
71104-035-0171104-486-0871104-804-01- Official label
- DailyMed (National Library of Medicine), updated May 5, 2023
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